Track topics on Twitter Track topics that are important to you
This is an open-label study to investigate the effects of the rivastigmine patch on attention and behavior in Parkinson's disease with Dementia (PDD). Rivastigmine is an FDA approved medication used for the treatment of mild to moderate Alzheimer's Disease (AD) and dementia due to Parkinson's disease. Recently a rivastigmine patch was developed, which has shown similar effectiveness with fewer side effects and increased caregiver preference when compared to capsules for the treatment of AD, but has had poor documentation when tested in PDD. This is an open-label 12 week study where 15 subjects diagnosed with PDD (people who have known Parkinson's Disease and have mild to moderate memory and/or thinking complaints) will be treated with the rivastigmine patch at UCSF. This study also analyzes the mechanism by which the rivastigmine patch works in PDD.
Upon referral to this study, subjects will undergo screening to ensure they meet inclusion criteria. At screening, participants will undergo an interview (prior medical & psychiatric history), neuropsychological testing, and physical & neurological exam, including UPDRS to measure parkinsonian symptoms and Hachinski score to measure cerebrovascular disease. At the end of the screening visit, the neurologist will evaluate whether the participant meets PDD research criteria and will also re-review the inclusion/exclusion criteria to ensure that the participants meets criteria for the study. All participants will undergo vital signs and an ECG to ensure minimal cardiovascular risk prior to receiving rivastigmine. Appropriate lab work will also be performed to exclude other potential causes of cognitive impairment.
At baseline visits, participants will undergo a short neurological exam, an MRI scan, attention testing, and a detailed behavioral assessment, after which they will be started on a 5cm2/24hr rivastigmine patch. After 4 weeks, the dose will be increased to a recommended target dose of 9.5cm2/24hr patch. At this visit a short neurological exam will also be conducted. After 12 weeks, participants will again undergo a short neurological exam, an fMRI scan, attention testing and a behavioral assessment. Adverse events and compliance will be assessed every 2 weeks of the study.
Informants will be asked to complete questionnaires regarding the primary participant at the baseline and 12 week visits.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Parkinsons Disease With Dementia
Rivastigmine Patch 9.5 cm2
University of California, San Francisco
Published on BioPortfolio: 2014-08-27T03:18:57-0400
This study will assess the efficacy of a higher dose of rivastigmine patch (15 cm2) compared to a lower dose of the rivastigmine patch (5 cm2), in patients with severe dementia of the Alzh...
The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underl...
This study will use two doses of rivastigmine transdermal patch (5cm2, 10cm2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without ...
The purpose of this study is to support the optimal use of rivastigmine patch in long-term treatment of AD in patients demonstrating cognitive decline at the target maintenance dose of riv...
Rivastigmine, an acetylcholinesterase inhibitor which has been approved by FDA & HSA, is authorized for use in the treatment of mild to moderate dementia of the Alzheimer's type. In this ...
Effects on agitation with rivastigmine patch monotherapy and combination therapy with memantine in mild to moderate Alzheimer's disease: a multicenter 24-week prospective randomized open-label study (the Korean EXelon Patch and combination with mEmantine Comparative Trial study).
Memantine is known to be effective in the treatment of the behavioral symptoms of dementia, especially agitation in moderate to severe Alzheimer's disease (AD). However, memantine and rivastigmine pat...
A 24-Week, Randomized, Controlled Study to Evaluate the Tolerability, Safety and Efficacy of 2 Different Titration Schemes of the Rivastigmine Patch in Japanese Patients with Mild to Moderate Alzheimer's Disease.
To investigate whether 1-step titration of the rivastigmine patch (initiated at 5 cm(2) and titrated to 10 cm(2) after 4 weeks) is well tolerated in Japanese patients with Alzheimer's disease (AD) as ...
Alzheimer's disease (AD) is one of the most important diseases in an aging society, but the clinical effects of rivastigmine have not been fully examined in real world domestic clinics.
Parkinson's disease is the second most frequent neurodegenerative disorder. There is significantly elevated risk of cognitive decline and associated neuropsychiatric symptoms. Dementia may develop ins...
Clinicians often have difficulty distinguishing between various forms of dementia to achieve a correct diagnosis. Little research has been done to examine whether awareness of one's cognitive deficits...
An electrophysiologic technique for studying cells, cell membranes, and occasionally isolated organelles. All patch-clamp methods rely on a very high-resistance seal between a micropipette and a membrane; the seal is usually attained by gentle suction. The four most common variants include on-cell patch, inside-out patch, outside-out patch, and whole-cell clamp. Patch-clamp methods are commonly used to voltage clamp, that is control the voltage across the membrane and measure current flow, but current-clamp methods, in which the current is controlled and the voltage is measured, are also used.
A medicated adhesive patch placed on the skin to deliver a specific dose of medication into the bloodstream.
Skin tests in which the sensitizer is applied to a patch of cotton cloth or gauze held in place for approximately 48-72 hours. It is used for the elicitation of a contact hypersensitivity reaction.
A familial disorder inherited as an autosomal dominant trait and characterized by the onset of progressive CHOREA and DEMENTIA in the fourth or fifth decade of life. Common initial manifestations include paranoia; poor impulse control; DEPRESSION; HALLUCINATIONS; and DELUSIONS. Eventually intellectual impairment; loss of fine motor control; ATHETOSIS; and diffuse chorea involving axial and limb musculature develops, leading to a vegetative state within 10-15 years of disease onset. The juvenile variant has a more fulminant course including SEIZURES; ATAXIA; dementia; and chorea. (From Adams et al., Principles of Neurology, 6th ed, pp1060-4)
Heterogeneous group of neurodegenerative disorders characterized by frontal and temporal lobe atrophy associated with neuronal loss, gliosis, and dementia. Patients exhibit progressive changes in social, behavioral, and/or language function. Multiple subtypes or forms are recognized based on presence or absence of TAU PROTEIN inclusions. FTLD includes three clinical syndromes: FRONTOTEMPORAL DEMENTIA, semantic dementia, and PRIMARY PROGRESSIVE NONFLUENT APHASIA.
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase 'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...
Dementia describes a range of symptoms of cognitive decline. For example memory loss, problems with reasoning and communication skills, and a reduction in a person's abilities and skills in carrying out daily activities. There are about 820,000 peo...